Iodine Supplement Strategies Between Routine Iodine Supplementation and Selective Iodine Supplementation

NCT ID: NCT03078140

Last Updated: 2018-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-05-31

Brief Summary

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Pregnant women who attend at our antenatal clinic will random to 2 groups. First will receive routine iodine supplementation. The other will receive iodinated pill or only iron supplementation base on their urine iodine status.

Detailed Description

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Conditions

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Pregnancy Related Iodine Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Triferdine

Triferdine 1 tablet by mouth daily. Start after 1st trimester until delivery

Group Type ACTIVE_COMPARATOR

Triferdine

Intervention Type DIETARY_SUPPLEMENT

Triferdine 1 tablet daily Start from 14 weeks of gestation until delivery

Triferdine/Ferli-6

Triferdine or ferli-6 1 tablet by mouth daily base on iodine status. The supplement will give after 1st trimester until delivery

Group Type ACTIVE_COMPARATOR

Triferdine/Ferli-6

Intervention Type DIETARY_SUPPLEMENT

For the participants assigned to this group, urine iodine level will be checked first.

For participants with normal urine iodine level, Ferli-6 1 tab daily will be given.

For those with low urine iodine level, Triferdine 1 tab daily will be given. Medication will be started from 14 weeks of gestation until delivery.

Interventions

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Triferdine

Triferdine 1 tablet daily Start from 14 weeks of gestation until delivery

Intervention Type DIETARY_SUPPLEMENT

Triferdine/Ferli-6

For the participants assigned to this group, urine iodine level will be checked first.

For participants with normal urine iodine level, Ferli-6 1 tab daily will be given.

For those with low urine iodine level, Triferdine 1 tab daily will be given. Medication will be started from 14 weeks of gestation until delivery.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* first visit for antenatal care in the first trimester
* singleton pregnancy
* delivered at Maharaj Nakorn Chiangmai Hospital

Exclusion Criteria

* thyroid disease which diagnosed before pregnancy or currently
* history of thyroid gland surgery or iodine ablation therapy
* received iodine supplement before pregnancy
* received any medication for thyroid disease treatment, within 6 weeks postpartum women or breast feeding period
* family history of thyroid disease
* having underlying disease or contraindication which cannot received iodine supplement
* loss follow-up or incomplete data.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chiang Mai University

OTHER

Sponsor Role lead

Responsible Party

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Kuntharee Traisrisilp

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kuntharee Traisrisilp

Chiang Mai, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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4298

Identifier Type: -

Identifier Source: org_study_id

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